Needle-implantable sensor with multi-sensing elements for accurate glucose monitoring

DESCRIPTION provided by applicant Over the past five years Biorasis Inc has been developing a totally implantable biosensor platform x x mm capable of continuously monitoring glucose The underlying principle in developing this miniaturized sensor hinges on extreme miniaturization utilizing light both as a powering source and a communication link Such implant size reduction results in minimal tissue damage during implantation The localized release of various tissue response modifiers has also afforded effective inflammation control and fibrosis suppression needed for long term sensor functionality The sensing element of this platform is based on a novel layer device architecture that yields high performance in terms of selectivity linearity response time and sensitivity In vivo studies have indicated an aggregate mean absolute relative difference MARD value of between our sensor measured glucose levels and reference standards over a period of days While this is already comparable to the transcutaneous sensors currently in market our analysis has shown that the sensor MARD values can be further lowered to if one takes into consideration the variability within the sensing element to permeability changes that affect the diffusion of glucose and other co substrates Objective Hypothesis Correlating the response of the glucose sensing element to the permeability changes for glucose and other co substrates can substantially improve sensor accuracy with MARD values down to for both hypo and hyperglycemic regions over extended periods of time months Study Design This Phase I study will be focused on proof of concept demonstration of the fully integrated device for month in normal and diabetic rats For this our current prototype device will be outfitted with a new electronic chip comprising of two additional potentiostats and sensor select circuitry along with the three sensing elements Furthermore wafer level integration and packaging of the micro optoelectronic components and sensing elements will be carried out for in vivo studies and validation Relevance In view of the growing number of diabetics worldwide there is a tremendous need for devices that provide accurate detection of glucose levels In lieu of the difficulties associated with glucose monitoring using non invasive methods extreme miniaturization of a totally implantable device together with assured accuracy and long term operation present a viable alternative The proposed multi sensing element platform addresses miniaturization and accurate glucose readings In addition the wireless communication and prolonged lifetime render it an effective device for diabetic care as well as a powerful tool for metabolite monitoring in pre clinical animal research PUBLIC HEALTH RELEVANCE The increasing occurrence of diabetes ca and million diabetic patients in US and rest of the world respectively poses a serious health problem especially considering the complications arising from renal failure amputations and other serious conditions The development of a continuous glucose monitoring system will provide the necessary warning to prevent hypo and hyper glycemic events as well as to minimize fluctuations in glucose levels that would otherwise lead to many debilitating complications associated with diabetes In addition the high measurement fidelity afforded by this device will allow safe and accurate glucose sensing that can advance the efforts to realize an artificial pancreas